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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05089292
Other study ID # STUDY-20-01174
Secondary ID R21CA249261
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date December 13, 2022

Study information

Verified date June 2024
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The long-term goal of this research is to increase breast cancer screening rates in NYC Chinese immigrants. The researchers plan to accomplish this objective by developing and testing a culturally- and linguistically-adapted Witness Project program for Chinese immigrants. To inform the intervention development, the study team will identify barriers and facilitators to breast cancer screening in Chinese immigrants through individual qualitative interviews. A total of 156 participants will be recruited during the entire study. In Aim 1 which started in July 2021, 60 women were recruited for in-depth interviews to assess their breast cancer knowledge, perceived barriers and benefits/risks to completing mammography, perceived susceptibility to breast cancer, fatalism, screening intention, acculturation, language preference, and health literacy. In Aim 2, 96 women will be recruited to participate in the pilot testing of the intervention. Recruitment will take place at community sites that serve Chinese immigrants in New York City. Enrollment for Aim 2 is anticipated to start in March of 2022.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date December 13, 2022
Est. primary completion date December 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years and older
Eligibility Inclusion Criteria: - = 40 years of age - female - born in China - read and speak Cantonese, Mandarin, or English Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Narrative breast health education
Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community

Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (2)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants That Scored Above 80% in the Feasibility and Acceptability Questionnaire Post-program survey to access acceptability of adapted narrative education program. Full-scale from 0% to 100%, with a higher percent indicating greater acceptability. An arbitrary cutoff value of 80% acceptance will determine the interventions' acceptability for the study. immediately post presentation (presentation approximately 1 hour)
Primary Number of Participants Who Were Engaged in Program Percent of participants who showed up to the Chinese-community-based organizations and would like to participate in the program to assess engagement rate of participants Baseline
Primary Percentage of Community Organizations Willing to Host Program Percentage of Chinese Community-based organizations who were willing to host the program to assess feasibility. Engagement rate of Chinese-community-based organizations was used to access feasibility 7 months
Secondary Change in Breast Cancer Knowledge Pre- and post-program survey to access change in breast cancer knowledge. Each correct answer counted as 1 point, each incorrect one as 0, and skipped questions as 0. Full scale from 0-6, with a higher score indicates more knowledge. baseline and 6 months post intervention
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